NDC 0378-8768

Buprenorphine and Naloxone

Buprenorphine And Naloxone

Buprenorphine and Naloxone is a Buccal; Sublingual Film in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

Product ID0378-8768_41e1c8fd-d42f-4e7d-aa5c-062764ac5aad
NDC0378-8768
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine and Naloxone
Generic NameBuprenorphine And Naloxone
Dosage FormFilm
Route of AdministrationBUCCAL; SUBLINGUAL
Marketing Start Date2019-02-20
Marketing CategoryANDA / ANDA
Application NumberANDA207607
Labeler NameMylan Pharmaceuticals Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active Ingredient Strength12 mg/1; mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-8768-93

30 POUCH in 1 CARTON (0378-8768-93) > 1 FILM in 1 POUCH (0378-8768-16)
Marketing Start Date2019-02-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8768-93 [00378876893]

Buprenorphine and Naloxone FILM
Marketing CategoryANDA
Application NumberANDA207607
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-20

NDC 0378-8768-16 [00378876816]

Buprenorphine and Naloxone FILM
Marketing CategoryANDA
Application NumberANDA207607
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-20

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE12 mg/1

OpenFDA Data

SPL SET ID:d1ecf0e8-7816-490e-b3c0-e929cb5f76de
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1010604
  • 1307061

    • Pharmacological Class

    • Partial Opioid Agonists [MoA]
    • Partial Opioid Agonist [EPC]
    • Opioid Antagonist [EPC]
    • Opioid Antagonists [MoA]

    NDC Crossover Matching brand name "Buprenorphine and Naloxone" or generic name "Buprenorphine And Naloxone"

    NDCBrand NameGeneric Name
    0228-3154Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0228-3155Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0378-8765Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0378-8766Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0378-8767Buprenorphine and Naloxonebuprenorphine and naloxone
    0378-8768Buprenorphine and Naloxonebuprenorphine and naloxone
    0781-7216BUPRENORPHINE AND NALOXONEbuprenorphine hydrochloride, naloxone hydrochloride
    0781-7249BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
    0781-7227BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
    0781-7238BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
    43598-579Buprenorphine and NaloxoneBuprenorphine and Naloxone
    43598-580Buprenorphine and NaloxoneBuprenorphine and Naloxone
    43598-582Buprenorphine and NaloxoneBuprenorphine and Naloxone
    43598-581Buprenorphine and NaloxoneBuprenorphine and Naloxone
    50383-294Buprenorphine and NaloxoneBuprenorphine and Naloxone
    50383-287Buprenorphine and NaloxoneBuprenorphine and Naloxone
    53217-138Buprenorphine and NaloxoneBuprenorphine and Naloxone
    60429-587Buprenorphine and NaloxoneBuprenorphine and Naloxone
    60429-586Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62175-452Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62756-969Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62175-458Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62756-970Buprenorphine and NaloxoneBuprenorphine and Naloxone
    63629-7270Buprenorphine and NaloxoneBuprenorphine and Naloxone
    70518-2327Buprenorphine and NaloxoneBuprenorphine and Naloxone
    70518-2311Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
    0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.